Cortex announced today that it began its RESOLVE-AF trial evaluating its Ablamap system with the newly release Ablacath mapping technology.
Launched by Ajax Health in December 2023, the company already offers the FDA-cleared Ablamap with electrographic flow (EGF). It seeks to pair the system with the newly released Ablacath mapping catheter to identify extra-pulmonary vein EGF sources.
Ablamap includes a workstation with software and monitor, amplifier and proprietary basket mapping catheter and cables.
EGF mapping allows physicians to detect EGF sources, leading to individualized ablation strategies and potentially improved outcomes. The trial aims to demonstrate that EGF mapping can identify EGF sources outside the pulmonary veins in all types of patients. That includes those with paroxysmal, persistent and long-standing persistent AFib, undergoing de novo or redo procedures.
RESOLVE-AF may enroll up to 400 subjects across more than 20 centers in the U.S. and Europe. It builds upon Cortex’s recently completed randomized, controlled FLOW-AF trial. That study looked at EGF-guided treatment of AFib sources in persistent AFib patients. It demonstrated improved freedom from AFib at one year post-ablation (51%).
Dr. David Haines, director of the Heart Rhythm Center at Corewell Health in Royal Oak, Michigan, serves as lead investigator. In a news release, Haines said the mapping technology could potentially “provide a much-needed solution” for identifying extra-pulmonary vein sources of AFib. He added that it could enable personalized, highly targeted treatment.